French Business Law - French Legislation

Article L5141-14-3 of the French Public Health Code

November 6, 2023

The use in veterinary medicine of medicinal products or medicated feedingstuffs containing one or more antibiotic substances is carried out in compliance with recommendations for good use designed to prevent the development of risks to human and animal health associated with antibiotic resistance, established, on a proposal from the Agence nationale chargée de la sécurité sanitaire de l’alimentation, de l’environnement et du travail and after obtaining the opinion of the…

Article L5141-14-4 of the French Public Health Code

November 6, 2023

I.-Any breach of the prohibitions set out in the first paragraph of article L. 5141-14-2 is punishable by an administrative fine of up to €15,000 for a natural person and up to €75,000 for a legal entity. II – The amount of the fine mentioned in I of this article is doubled if the breach is repeated within two years of the date on which the first penalty decision became…

Article L5141-14-5 of the French Public Health Code

November 6, 2023

The dispensing of certain medicinal products by pharmacists or veterinary surgeons, where their pharmaceutical form so permits, may be by the unit, provided that the integrity of the immediate packaging and the conditions laid down in the marketing authorisation are respected.

Article L5141-15 of the French Public Health Code

November 6, 2023

Veterinarians established in another Member State of the European Union performing professional acts on an occasional basis, after having declared themselves as service providers, are subject to the provisions of Article 111 of Regulation (EU) 2019/6 of 11 December 2018 and to the regulatory provisions adopted pursuant to this Article. These veterinarians are subject to the rules on prescribing and dispensing set out in Article L. 5143-5.

Article L5141-15-1 of the French Public Health Code

November 6, 2023

Health professionals, establishments, persons or organisations appearing on a list established by decree in the Conseil d’Etat are required to declare any effects likely to be attributed to the use of a veterinary medicinal product. This decree also determines the obligations of these professionals with regard to the declaration of the effects of a medicinal product for human use administered to an animal, including under the conditions provided for in…

Article L5141-16 of the French Public Health Code

November 6, 2023

The following shall be determined, as necessary, by decree in the Conseil d’Etat: 1° The conditions under which the additional information provided for in Article 13 of Regulation 2019/6 of 11 December 2018 may be displayed on the immediate packaging or outer packaging of veterinary medicinal products ; 2° The procedures applicable to applications for a marketing authorisation for a veterinary medicinal product and to variations thereto, as well as…

Article L5142-1 of the French Public Health Code

November 6, 2023

I.-The manufacture, import, export and wholesale distribution of veterinary medicinal products, and the manufacture, import and distribution of medicinal products subject to clinical trials, are carried out by establishments governed by Regulation (EU) 2019/6 of 11 December 2018 and by this chapter. II.-In each establishment authorised under Article 88 of Regulation (EU) 2019/6 of 11 December 2018, a qualified person is responsible in particular for carrying out the tasks specified…

Article L5142-1-1 of the French Public Health Code

November 6, 2023

The manufacture of autovaccines for veterinary use referred to in paragraph 3 of Article 2 of Regulation (EU) 2019/6 of 11 December 2018 is carried out by a qualified person or a company or body employing a qualified person who has obtained an authorisation for this purpose issued by the National Agency for Food, Environmental and Occupational Health Safety. This activity is subject to pharmacovigilance obligations, the content of which…

Article L5142-1-2 of the French Public Health Code

November 6, 2023

The preparation of veterinary medicinal products not falling within the scope of Regulation (EU) 2019/6 of 11 December 2018, excluding extemporaneous preparations, is carried out by a qualified person or a company or body employing a qualified person who has obtained an authorisation for this purpose issued by the National Agency for Food, Environmental and Occupational Health Safety. This activity is subject to pharmacovigilance obligations, the content of which is…

Article L5142-1-3 of the French Public Health Code

November 6, 2023

When carrying out their activity on national territory, the qualified person in pharmacovigilance referred to in paragraph 8 of Article 77 of Regulation (EU) 2019/6 of 11 December 2018 shall have professional premises. Their activity shall be subject to a declaration to the Director General of the National Agency for Food, Environmental and Occupational Health Safety.

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French Public Health Code

Article L5141-14-3 of the French Public Health Code

Article L5141-14-4 of the French Public Health Code

Article L5141-14-5 of the French Public Health Code

Article L5141-15 of the French Public Health Code

Article L5141-15-1 of the French Public Health Code

Article L5141-16 of the French Public Health Code

Article L5142-1 of the French Public Health Code

Article L5142-1-1 of the French Public Health Code

Article L5142-1-2 of the French Public Health Code

Article L5142-1-3 of the French Public Health Code

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French Public Health Code

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